北京招聘

Job Purpose:
The Safety Scientist is responsible for carrying out pharmacovigilance activities on a product or group of products, including
single case processing, aggregate reporting, signal detection and evaluation of PV database
The Safety Scientist supports the Safety Science Leader and is responsible for a particular aspect(s) or segments of the
overall programme. The job-holder contributes to the benefit risk evaluation and to safety risk management



Primary Responsibilities and Accountabilities:
Carry out pharmacovigilance and risk management activities for specific product or products:

Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and highlighting and tracking potential issues

Support the preparation and maintenance of Risk Management plans for the submission to Regulatory Authorities

Prepare and review periodic safety reports (PSUR, EU Annual Safety Reports) in accordance with regulatory
requirements and standard operating procedures

Support the preparation and maintenance of safety sections of the Company Core Data Sheet

Lead/support PDS post-marketing safety study activities

Coordinate safety activities between PDS and internal and external partners
Carry out signal detection activities and evaluation:

Conduct/support signal detection and evaluation according to SOPs and guidelines

Carry out medical review of spontaneous case reports and Serious Adverse Event reports from clinical trials, according to SOPs and guidelines

Prepare Drug Safety reports, as necessary, for potential signals

Respond to queries relevant to the safety of Roche products from the affiliates and other internal functions
Contribute drug safety input to activities to define and implement the Clinical Development strategy for a product or group of products:

Provide review of clinical protocols and study reports to ensure alignment with CDP and safety adequately addressed, and contributes to the safety section of the Investigators Brochure (IB)

Contribute to regulatory authority submissions (NDAs, MAA's, Variations) by reviewing safety data and preparing relevant sections of the submission

Participate in or provide input for Drug Safety Monitoring Boards, as necessary

Provide support to the SSL

In the case of early projects support the SSL by developing a clear understanding of the safety issues from the drug mechanism the timely medically and scientifically sound development of the clinical safety portions of a product development plan
(PDP)
Whenever assigned by the SSL, is responsible for the development and whenever appropriate the execution of RMP or REMS risk mitigation tactics.

罗氏药品临床研发亚太中心

罗氏药品临床研发亚太中心位于上海张江高科技园区，是罗氏在中国乃至亚太地区（不包括日本在内）第一个全功能临床药品开发中心，是罗氏药品开发部在全球的第五个研发地区。其前身为2007年10月成立的罗氏药品开发中国中心。

罗氏于2007年在中国率先设立全球药品开发中心，成为在华完成且体现药物研究、药品开发、生产制造和市场销售环节等整体价值链布局的跨国制药企业。此举不仅将加快新药在华的上市时间，使国内广大患者有望更早地受益于创新药物，而且将让更多的中国研究机构、学者、临床医生更早、更主动地参与到全球创新药物的开发过程。

罗氏药品开发中国中心从事药品开发工作，是把经过实验室筛选的分子转变成药物的关键一环，它通过国际多中心临床研究，鉴定药物的安全性和有效性，是驱动药物价值链的引擎。罗氏药品开发中国中心于2009年9月升级为罗氏药品临床研发亚太中心，负责罗氏在亚太地区的药品开发，令更多中国乃至亚太地区的患者尽早受益。